Fosamax
As
previously disclosed, Merck is a defendant in product liability lawsuits in the
United States
involving Fosamax (the “Fosamax Litigation”). As of DecemberMarch 31, 20122013, approximately 4,560990 cases, which include approximately 5,140585 plaintiff groups, had been filed and were
pending against Merck in either federal or state court, including one case
which seeks class action certification, as well as damages and/or medical
monitoring. In approximately 1,230210 of these actions, plaintiffs allege,
among other things, that they have suffered osteonecrosis
of the jaw (“ONJ”), generally subsequent to invasive dental
procedures, such as tooth extraction or dental implants and/or delayed healing,
in association with the use of Fosamax. In
addition, plaintiffs in approximately 3,330780 of these actions generally allege that
they sustained femur fractures and/or other bone injuries (“Femur
Fractures”) in association with the use of Fosamax.
Cases Alleging ONJ and/or Other Jaw Related Injuries
In August 2006, the Judicial Panel on Multidistrict
Litigation (the “JPML”) ordered that certain Fosamax
product liability cases pending in federal courts nationwide should be
transferred and consolidated into one multidistrict litigation (the “Fosamax ONJ MDL”) for coordinated pre-trial
proceedings. The Fosamax ONJ MDL has
been transferred to Judge John Keenan in the U.S. District Court for the
Southern District of New York. As a result of the JPML order, approximately 960940 of the cases are before Judge Keenan. In
the first Fosamax ONJ MDL trial, Boles v.
Merck, the Fosamax ONJ MDL court
declared a mistrial because the eight person jury could not reach a unanimous
verdict. The Boles case was retried in June 2010 and resulted in a
verdict in favor of the plaintiff in the amount of $8 million. Merck filed
post-trial motions seeking judgment as a matter of law or, in the alternative,
a new trial. In October 2010, the court denied Merck’s post-trial motions
but sua sponte ordered
a remittitur reducing the verdict to
$1.5 million. Plaintiff rejected the remittitur
ordered by the court and requested a new trial on damages. Plaintiff and Merck
subsequently entered into a confidential stipulation as to the amount of
plaintiff’s damages that enabled Merck to appeal the underlying judgment,
and Merck filed its appeal in the Boles case onin
October 18,
2012. Prior to 2013, three other cases were tried to verdict in the Fosamax ONJ MDL. Defense verdicts in favor of Merck
were returned in each of those three cases. Plaintiffs have filed an appeal in
two of the cases – Graves v. Merck and Secrest
v. Merck. On January 30, 2013, the U.S. Court of Appeals for the
Second Circuit affirmed the judgment in Merck’s favor in Secrest. On
April 30, 2013, plaintiff in the Secrest case
filed a petition for writ of certiorari with the U.S. Supreme Court.
In February 2011, Judge Keenan ordered that there will
be two further bellwether trials conducted in the Fosamax
ONJ MDL. Spano v. Merck and Jellema v. Merck were selected by the court
to be tried in 2012, but each case was dismissed by the plaintiffs. OnIn March 28, 2012, the court selected Scheinberg v. Merck as the next case to be
tried. Trial in the Scheinberg case began on
January 14, 2013 and, on February 5, 2013, the jury returned a mixed
verdict, finding in
favor of Merck on plaintiff’s design defect claim, and finding in favor of plaintiff on her
failure to warn claim and awarding
her $285 thousand in compensatory damages. On March 5, 2013, Merck filed a post-trial motion
for judgment as a matter of law in the Scheinberg
case and that motion is still pending.
Outside
the Fosamax ONJ MDL, in Florida, Carballo v. Merck was set for
trial on October 15, 2012, but plaintiff dismissed the case and refiled it
in the Fosamax ONJ MDL. Anderson v. Merck had been set for trial
on January 14, 2013, but plaintiff dismissed the case prior to trial.In November 2011, Judge Keenan issued an
order requiring plaintiffs who do not allege certain types of specific injuries
to provide expert reports in support of their claims. The deadlines for
submission of these reports are staggered throughout the first half of 2013,
and failure to comply with the order may result in dismissal of a
plaintiff’s claim. The first deadline passed on February 20, 2013,
and Merck submitted to the court on February 27, 2013 a list of several
hundred plaintiffs who failed to comply with that first deadline. On
March 13, 2013, Judge Keenan ordered that those plaintiffs who failed to
provide reports by the February 20, 2013 deadline had 30 days to provide
the required reports or, upon motion, the case may be dismissed with prejudice
and/or the court may impose sanctions for failure to comply. To date, more than
225 plaintiffs subject to the order have dismissed their claims with prejudice.
In addition, in July 2008, an application was made by
the Atlantic County Superior Court of New Jersey
requesting that all of the Fosamax cases
pending in New Jersey be considered for mass
tort designation and centralized management before one judge in New Jersey. In October
2008, the New Jersey Supreme Court ordered that all pending and future actions
filed in New Jersey arising out of the use of Fosamax
and seeking damages for existing dental and jaw-related injuries, including
ONJ, but not solely seeking medical monitoring, be designated as a mass tort
for centralized management purposes before Judge Carol E. Higbee
in Atlantic County Superior Court. As of DecemberMarch 31, 20122013, approximately 260265 ONJ cases were pending against Merck in Atlantic County, New
Jersey. In July 2009, Judge Higbee
entered a Case Management Order (and various amendments thereto) setting forth
a schedule that contemplates completing fact and expert discovery in an initial
group of cases to be reviewed for trial. In February 2011, the jury in Rosenberg v.
Merck, the first trial in the New
Jersey coordinated proceeding, returned a verdict in
Merck’s favor. In April 2012, the jury in Sessner
v. Merck, the second case tried in New
Jersey, also returned a verdict in Merck’s
favor. Plaintiffs have filed an appeal in both cases. On March 25, 2013, the New Jersey Appellate Division
affirmed the judgment in Merck’s favor in the Rosenberg case.
In California,
the parties are reviewing the claims of two plaintiffs in the Carrie Smith,
et al. v. Merck case and the claims in Pedrojetti
v. Merck. The cases of one or more of these plaintiffs may be tried in
2013.
Discovery is ongoing in the Fosamax
ONJ MDL litigation, the New
Jersey coordinated proceeding, and the remaining jurisdictions
where Fosamax ONJ cases are pending.
The Company intends to defend against these lawsuits.
Cases Alleging Femur Fractures
In March 2011, Merck submitted a Motion to Transfer to
the JPML seeking to have all federal cases alleging Femur Fractures
consolidated into one multidistrict litigation for
coordinated pre-trial proceedings.
The Motion to Transfer was granted in May
2011, and all federal cases involving allegations of Femur Fracture have been
or will be transferred to a multidistrict litigation in the District of New
Jersey (the “Fosamax Femur Fracture
MDL”). As a result of the JPML order, approximately 8201,015 cases were pending in the Fosamax Femur Fracture MDL as of December March 31, 2012.2013. A Case Management Order has been
entered that requires the parties to review 40 cases (later reduced to 33
cases). Judge Joel Pisano has selected four cases from that group to be tried
as the initial bellwether cases in the Fosamax
Femur Fracture MDL and has set an
April 8, 2013 trial date for the . The first bellwether case, which will be Glynn v.
Merck, began on April 8,
2013 and the jury returned a verdict in Merck’s favor on April 29,
2013. The Zessin v. Merck
case is was set to be tried in
September 2013; the Young v.
Merck case is set to be tried in but has been
rescheduled for January 2014; the Young v. Merck and the Johnson v. Merck
case is setcases are expected to be
tried later in May 2014.
As of DecemberMarch 31, 20122013, approximately 2,075305 cases alleging Femur Fractures have been
filed in New Jersey
state court and are pending before Judge Higbee in
Atlantic County Superior Court. The parties have selected an initial group of
30 cases to be reviewed through fact discovery. Judge Higbee has set March 11, 2013 as the date for
the The first
trial of the New Jersey
state Femur Fracture cases, which
will be Su v. Merck, began on March 11, 2013, but a mistrial was
declared on March 28, 2013 after the plaintiff suffered a serious medical
issue unrelated to her use of Fosamax that
prevented her from proceeding with the trial. The next trial, Unanski v. Merck, is currently set to be
tried beginning November 4, 2013.
As of DecemberMarch 31, 20122013, approximately 420440 cases alleging Femur Fractures have been
filed in California
state court. A petition was filed seeking to coordinate all Femur Fracture
cases filed in California state court before a
single judge in Orange County,
California. The petition was
granted and Judge Steven Perk is now presiding over the coordinated
proceedings. No scheduling order has yet been entered.
Additionally, there are eightnine Femur Fracture cases pending in other
state courts. A trial date has been set for August 12, 2013 for the Barnes
v. Merck case pending in Alabama
state court.
Discovery is ongoing in the Fosamax
Femur Fracture MDL and in state courts where Femur Fracture cases are
pending and the Company intends to defend against these lawsuits.
Januvia/Janumet
As of March 31, 2013, there were 43
filed complaints against Merck alleging that plaintiffs’ use of Januvia and/or Janumet
caused them to develop pancreatic cancer. These complaints were filed in
several different state and federal courts, with the majority filed in the
United States District Court for the Southern District of California. On
April 5, 2013, a law firm representing certain plaintiffs filed a request
with the JPML to create a federal MDL for lawsuits alleging pancreatic cancer
due to use of the following medicines: Januvia,
Janumet, and Byetta and
Victoza, the latter two of which are products
manufactured by other pharmaceutical companies. In its MDL request, the law
firm asked the JPML to appoint Judge Anthony Battaglia
of the United States District Court for the Southern District of California as
the MDL Judge. On April 29, 2013, Merck and the other defendant manufacturers
individually filed responses, all of which agreed that Judge Battaglia should preside if the JPML determines that an MDL
is warranted. The Company intends to defend against these lawsuits.